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FDA Inspection
•Ekos America, Inc.•November 19, 2024

Ekos America, Inc. – FDA Inspection, Nov 19, 2024

Record Details

This FDA Inspection record concerns Ekos America, Inc., with an inspection on November 19, 2024, issued by the New York District Office, covering foods & cosmetics.

Company
Ekos America, Inc.
Inspection Date
November 19, 2024
Product Type
Foods & Cosmetics
Office
New York District Office
Person
  • Maximillian Lucci (Issuing Officer)
View Company Profile

ID · c22764db-4ec1-4064-958a-943e16361693

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1254560
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 1.505(d)Evaluation, reevaluation - another entity
  2. 21 CFR 1.506(a)(2)Approved supplier procedures- another entity
  3. 21 CFR 1.504(a)Hazard analysis written
  4. 21 CFR 1.510(b)(1)Record - translate to English

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ekos America, Inc.

3
DateClassificationOfficeProject area
December 5, 2025VAINew York District OfficeFoodborne Biological Hazards
November 22, 2023VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
September 14, 2022VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Ekos America, Inc.
  • FDA Inspection 1294032 - 2025-12-05
  • FDA Inspection 1223335 - 2023-11-22
  • FDA Inspection 1179651 - 2022-09-14

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